FDA.report

UniCel DxH 690T Coulter Cellular Analysis System

Primary DI
15099590729110
Brand
UniCel DxH 690T Coulter Cellular Analysis System
Company
Beckman Coulter, Inc.
Model
C34520
Catalog number
C34520
Device description
UniCel DxH 690T Coulter Cellular Analysis System
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GKZCounter, Differential Cell

Product Code Classifications

CodeDeviceSpecialtyClass
GKZCounter, Differential CellHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15099590729110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1509959072911015099590729110

GMDN Terms

TermDefinition
Haematological cell analyser IVD, automatedAn electrically-powered laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008254708
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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